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Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide

Primary Purpose

Ovarian Hyperstimulation Syndrome

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Norprolac
Norprolac
Norprolac
Norprolac
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ovarian Hyperstimulation Syndrome

Eligibility Criteria

21 Years - 37 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria Signed Informed Consent Form, prior to screening evaluations In good physical and mental health Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility Exclusion Criteria Any clinically significant systemic disease Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) History of recurrent miscarriage Undiagnosed vaginal bleeding

Sites / Locations

  • IVI Barcelona, Ronda General Mitre, 14
  • IVI Bilbao, Paseo Landabarri, 1
  • IVI Madrid, Santiago de Compostela, 88
  • IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
  • IVI Sevilla, Avda. República Argentina, 58
  • IVI Valencia, Plaza de la Policía Local, 3
  • IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Daily Tablets Dosing

Daily Tablets Dose

Daily Tablets Dosing

Daily Tablets Dosing

Outcomes

Primary Outcome Measures

OHSS

Secondary Outcome Measures

Full Information

First Posted
May 23, 2006
Last Updated
May 18, 2011
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00329693
Brief Title
Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide
Official Title
A Randomised, Double-blind, Parallel Groups, Dose-finding, Placebo-controlled, Multi-centre, Proof of Concept Study Assessing the Effect of 3-wk Treatment With 1 of 3 Oral Doses of Quinagolide & Placebo in Preventing Ovarian Hyperstimulation Syndrome in Women Undergoing Controlled Ovarian Hyperstimulation.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Women included in this study are undergoing controlled ovarian hyperstimulation for assisted reproductive technologies (ART) and present with signs of moderate risk of developing OHSS.
Detailed Description
No data to be entered.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Hyperstimulation Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
182 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Placebo Comparator
Arm Description
Daily Tablets Dosing
Arm Title
2
Arm Type
Experimental
Arm Description
Daily Tablets Dose
Arm Title
3
Arm Type
Experimental
Arm Description
Daily Tablets Dosing
Arm Title
4
Arm Type
Experimental
Arm Description
Daily Tablets Dosing
Intervention Type
Drug
Intervention Name(s)
Norprolac
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Norprolac
Intervention Description
Quinagolide
Intervention Type
Drug
Intervention Name(s)
Norprolac
Intervention Description
Quinagolide
Intervention Type
Drug
Intervention Name(s)
Norprolac
Intervention Description
Quinagolide
Primary Outcome Measure Information:
Title
OHSS
Time Frame
41 days after hCG injection

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Signed Informed Consent Form, prior to screening evaluations In good physical and mental health Pre-menopausal females between the ages of 21-37 years (both inclusive) at the time of randomisation Infertility for at least 1 year before randomisation, except for proven bilateral tubal infertility Exclusion Criteria Any clinically significant systemic disease Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) History of recurrent miscarriage Undiagnosed vaginal bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
IVI Barcelona, Ronda General Mitre, 14
City
Barcelona
ZIP/Postal Code
08017
Country
Spain
Facility Name
IVI Bilbao, Paseo Landabarri, 1
City
Leioa-Bizkaia
ZIP/Postal Code
48940
Country
Spain
Facility Name
IVI Madrid, Santiago de Compostela, 88
City
Madrid
ZIP/Postal Code
28035
Country
Spain
Facility Name
IVI Murcia, Navegante Macías del Poyo, 5, Edificio Delfín-Barrio La Flota
City
Murcia
ZIP/Postal Code
30007
Country
Spain
Facility Name
IVI Sevilla, Avda. República Argentina, 58
City
Sevilla
ZIP/Postal Code
41011
Country
Spain
Facility Name
IVI Valencia, Plaza de la Policía Local, 3
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
IVI Vigo, Plaza Francisco Fernández del Riego, 7 (Plaza Elíptica)
City
Vigo (Pontevedra)
ZIP/Postal Code
36203
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
33851429
Citation
Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.
Results Reference
derived
PubMed Identifier
20139430
Citation
Busso C, Fernandez-Sanchez M, Garcia-Velasco JA, Landeras J, Ballesteros A, Munoz E, Gonzalez S, Simon C, Arce JC, Pellicer A. The non-ergot derived dopamine agonist quinagolide in prevention of early ovarian hyperstimulation syndrome in IVF patients: a randomized, double-blind, placebo-controlled trial. Hum Reprod. 2010 Apr;25(4):995-1004. doi: 10.1093/humrep/deq005. Epub 2010 Feb 6.
Results Reference
derived

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Study Assessing the Effect of 3-week Treatment With One of Three Oral Doses of Quinagolide

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